K163480 is an FDA 510(k) clearance for the Renamel NANO +plus. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on February 24, 2017, 74 days after receiving the submission on December 12, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K163480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2016 |
| Decision Date | February 24, 2017 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |